The NIH Center for Regenerative Medicine (NIH CRM) represents a new initiative within the intramural research program, which is supported by the Common Fund. NIH CRM aims to be a foundation for excellence in stem cell research, with a focus on induced pluripotent stem cell (iPSC) technology and clinical translation. This facility is embedded within the NIH IRP and capitalizes on the substantive expertise relevant to the development and clinical applications of stem cells. The Center will capitalizing on the high throughput capabilities of the NCGC and the unique clinical research opportunities provided by the NIH Clinical Center. During the 2011 fiscal year, the NIH CRM made great strides toward establishing itself as a resource for the clinical translation of stem cells. Under the leadership of John OShea, the center was able to meet one of its most critical goals of recruiting a world-renowned expert in the field of stem cell biology, Mahendra Rao. Dr. Rao is a former NIH investigator who has significant experience working not only in regulatory affairs but also in industry developing tools and reagents related to stem cell research and translation. During the recruitment phase, the NIH CRM initiated three main efforts aimed at enhancing stem cell research within the intramural research program: providing training to intramural researchers in iPSC generation and culture methods;co-sponsoring with the NIH Stem Cell Interest Group both the Stem Cell Seminar Series and the inaugural Stem Cell Research Symposium;and providing support for clinically translatable stem cell projects. Through these efforts, NIH CRM has been able to equip labs with knowledgeable researchers, provide a forum for the investigators to share their work and opportunities to develop collaborations. With the Director recruitment now completed, the Center has continued the progress begun by Dr. OShea and has started to implement the vision of its Director for how to most rapidly leverage its resources and relationships to make stem cell therapy a clinical reality. Dr. Rao has been focusing in part on developing relationships with groups on campus that are working with iPSCs, ESCs, and adult stem cells. The initial meetings have identified existing bottlenecks to clinical translation for intramural stem cell research that could potentially be alleviated by the Center. Many of the issues identified, especially for iPSC work, were found to relate to the lack of common standards and the availability of well characterized control lines and tools to reliably generate integration free clinical grade lines engineered or repaired for either therapeutic or screening purposes. In addition to developing the necessary administrative and oversight infrastructure for the Center Dr. Rao has focused on recruiting Center staff, creating a standard consent form for generating iPSCs, developing a book of protocols for working with pluripotent stem cells, and designing an NIH CRM website. At the same time, Dr. Rao is establishing lines of communication with extramural program officers who work in stem cells in order to coordinate activities and ensure that the Center funds complementary and synergistic activities. In addition the staff at NIH CRM have been working with representatives from the FDA, NIST and other government agencies involved in the regulatory process of cell therapies to provide researchers with the appropriate information and materials to efficiently move through the regulatory approval process. Simultaneously, NIH CRM is making standards and controls available to FDA and NIST researchers to coordinate the development of qualification criteria and validation assays. NIH CRM is working with the NHLBI iPSC Core to culture and characterize a set of control and reporter iPSC lines that will be deposited in a non-profit cell bank and distributed to both intramural and extramural researchers. While the Center hopes in the future to be able to provide many services directly to the IRP, in order to fast-track the availability of services to the IRP, NIH CRM is currently establishing model contracts with companies to provide access to iPSC generation, differentiation and genetic engineering services. To make sure all cell lines generated at NIH can meet FDA and IRB standards, NIH CRM is working with NIAMS and NHLBI investigators to get approval for standard consent language for generating iPSCs. In the future NIH CRM will continue to build on the infrastructure and processes it has begun to establish and will utilize these to facilitate the clinical translation of key therapeutic initiatives developed by the IRP.